Clovis Oncology (CLVS) Reports FDA Doesn't Plan to Hold Advisory Committee Meeting on Rucaparib NDA

September 8, 2016 9:28 AM EDT

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Clovis Oncology (NASDAQ: CLVS) today disclosed in an SEC filing:

The Food and Drug Administration (“FDA”) has notified Clovis Oncology, Inc. (the “Company”) that FDA is not currently planning to hold an advisory committee meeting to discuss the Company’s New Drug Application for rucaparib. As previously announced by the Company, FDA has accepted the Company’s NDA for accelerated approval of rucaparib and granted priority review status to the application with a Prescription Drug User Fee Act (PDUFA) date of February 23, 2017.



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